Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a comprehensive Phase I multi-dose program with its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation today at the Endocrine Society Annual Meeting in Boston, June 4-7, 2011.
In the Phase I clinical trial, the safety, tolerability and preliminary efficacy of LGD-4033 was evaluated in a double-blind, placebo-controlled, multiple ascending dose study. Healthy male subjects were randomized to receive 0.1, 0.3 or 1.0 mg LGD-4033 or placebo once daily over 21 days.
The key findings include:
- LGD-4033 was safe and well tolerated at all doses following daily oral administration for three weeks in young healthy males
- No clinically significant dose-related adverse events were reported
- No clinically significant changes in liver function tests, PSA, hematocrit or ECG were seen
- Positive dose-dependent trends in lean muscle mass increase were observed with drug-treated subjects
- Positive dose-dependent trends in functional exercise and strength measures were consistent with anabolic activity
"LGD-4033 is a potentially best-in-class molecule in the muscle loss/wasting therapeutic arena, an area of medicine that is desperately in need of new medicines," said Shehzad Basaria, M.D., Associate Professor of Medicine and Director, Androgen Clinical Research Unit at Boston University School of Medicine and the co-principal investigator of the LGD-4033 Phase I multiple ascending dose study. "With decades of experimental evidence suggesting the anabolic potential of androgens, the need for a SARM that does not possess the side effects of androgens while retaining the therapeutic benefits is extremely compelling," added Dr. Basaria. "The positive trends in efficacy seen from this study are very exciting considering the study was not powered to show clear benefits in these endpoints," continued Dr. Basaria.
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